FDA 510(k) Application Details - K003577

Device Classification Name Light, Surgical, Fiberoptic

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510(K) Number K003577
Device Name Light, Surgical, Fiberoptic
Applicant STERIS Corporation
2720 GUNTER PARK EAST
MONTGOMERY, AL 36109 US
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Contact RAYMOND URSICK
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Regulation Number 878.4580

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Classification Product Code FST
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Date Received 11/20/2000
Decision Date 01/29/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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